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Treatment of Bevacizumab and Triamcinolone in Treatment or Macular Edema Secondary to CRVO (MECROV)

Primary Purpose

Macular Edema, Central Retinal Vein Occlusion

Status

Unknown status

Phase

Phase 4

Locations

Mexico

Study Type

Interventional

Intervention

bevacizumab and triamcinolone

About this trial

This is an interventional treatment trial for Macular Edema focused on measuring Macular edema, central retinal vein occlusion, bevacizumab, triamcinolone

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Macular edema secondary to central retinal vein occlusion
BCVA worse than 20/40
Central macular >250 mc with OCT

Exclusion Criteria:

Diabetic retinopathy or other retinopathy
Media opacity that does not allow following
steroid responder
diagnosed glaucoma or IOP > 21 mmHg

Sites / Locations

Asociacion Para Evitar la Ceguera en MexicoRecruiting

Outcomes

Primary Outcome Measures

Changes in Best corrected visual acuity and macular edema measured with OCT

Secondary Outcome Measures

Report treatment complications

Full Information

NCT ID

NCT00566761

First Posted

November 30, 2007

Last Updated

November 30, 2007

Sponsor

Asociación para Evitar la Ceguera en México

1. Study Identification

Unique Protocol Identification Number

NCT00566761

Brief Title

Treatment of Bevacizumab and Triamcinolone in Treatment or Macular Edema Secondary to CRVO

Acronym

MECROV

Official Title

Combined Treatment of Intravitreous Bevacizumab and Triamcinolone for the Treatment or Macular Edema Secondary to Central Retinal Vein Occlusion

Study Type

Interventional

2. Study Status

Record Verification Date

November 2007

Overall Recruitment Status

Unknown status

Study Start Date

June 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

March 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Asociación para Evitar la Ceguera en México

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Treatment of macular edema secondary to central retinal vein occlusion is more effective with combined therapy of bevacizumab and triamcinolone than bevacizumab alone.

Detailed Description

Comparison of two groups with different treatment with registrations of outcome in BCVA and complications

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Macular Edema, Central Retinal Vein Occlusion

Keywords

Macular edema, central retinal vein occlusion, bevacizumab, triamcinolone

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

bevacizumab and triamcinolone

Intervention Description

three applications monthly administrated of bevacizumab 2.5mg for group 1 and bevacizumab 2.5 mg + triamcinolone 4mg first dose followed by two of bevacizumab alone for the group 2

Primary Outcome Measure Information:

Title

Changes in Best corrected visual acuity and macular edema measured with OCT

Time Frame

Follow up to 3 , 6 and 12 months

Secondary Outcome Measure Information:

Title

Report treatment complications

Time Frame

12 month

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Macular edema secondary to central retinal vein occlusion BCVA worse than 20/40 Central macular >250 mc with OCT Exclusion Criteria: Diabetic retinopathy or other retinopathy Media opacity that does not allow following steroid responder diagnosed glaucoma or IOP > 21 mmHg

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Carmen Conzalez-Mijares, Physician

Phone

5517638245

cacegomi@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carmen Gonzalez-Mijares, Physician

Organizational Affiliation

Asociación para Evitar la Ceguera en México

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Hugo Quiroz-Mercado, Retinologyst

Organizational Affiliation

Asociación para Evitar la Ceguera en México

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Juan Manuel Jimenez Sierra, Retinologyst

Organizational Affiliation

Asociación para Evitar la Ceguera en México

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

MA Martinez-Castellanos, Physician

Organizational Affiliation

Asociación para Evitar la Ceguera en México

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Octavio Burgos Vejar, Physician

Organizational Affiliation

Asociación para Evitar la Ceguera en México

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Raul Velez-Montoya, Physician

Organizational Affiliation

Asociación para Evitar la Ceguera en México

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Ma de Lourdes Lopez Ramos, Physician

Organizational Affiliation

Asociación para Evitar la Ceguera en México

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Omar Honerlager, preresident

Organizational Affiliation

Asociación para Evitar la Ceguera en México

Official's Role

Study Chair

Facility Information:

Facility Name

Asociacion Para Evitar la Ceguera en Mexico

City

Mexico city

State/Province

Coyoacan

ZIP/Postal Code

04030

Country

Mexico

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Retina Department

Phone

5510841400

Ext

1171

retinamex@yahoo.com

12. IPD Sharing Statement

Learn more about this trial

Treatment of Bevacizumab and Triamcinolone in Treatment or Macular Edema Secondary to CRVO

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